Isolation/Containment chambers to isolate
patient and protect health care providers. In
case of disease out break, terrorist
contamination
Particulate Filteration efficiency / material: National Institute for Occupational Safety and Health. NIOSH Certified TC-84A-4350, Bacterial filteration efficiency, Differential pressure.
Particulate Filteration efficiency / material: National Institute for Occupational Safety and Health. NIOSH Certified TC-84A-4350, Bacterial filteration efficiency, Differential pressure.
Compliance Consultants has worked on these devices
as Class II and drafted 510K submissions.
This is part of the surgical apparel classification that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Class II (special controls) for surgical gowns and surgical masks.
Various personnel and authorities may be involved in the proper deployment and use of this system. Consideration for the on-scene command, support crew, health care providers and the patient must apply for a successful deployment.
21 CFR 878.4040, Product Code FYC, Body fluid resistance ASTM F1862, AAMI/ANSI ST65:2008 Processing of reusable surgical textiles for use in health care facilities, ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities, CDRH Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical Drapes
This is part of the surgical apparel classification that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Class II (special controls) for surgical gowns and surgical masks.
Various personnel and authorities may be involved in the proper deployment and use of this system. Consideration for the on-scene command, support crew, health care providers and the patient must apply for a successful deployment.
21 CFR 878.4040, Product Code FYC, Body fluid resistance ASTM F1862, AAMI/ANSI ST65:2008 Processing of reusable surgical textiles for use in health care facilities, ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities, CDRH Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical Drapes
